The PositionPerform & review analysis of in-process, release & stability samples of API and/or filled product in accordance with cGMP, site & corporate policies & procedures. Transfer of technology & processes in accordance with relevant project plans & timelines. Provide leadership for other analysts as they execute their daily tasks.
RelationshipsReports to Manager.
Essential Functions- Ensure accuracy & scientific soundness of lab data
- Endure environnemental compliance
- Support & ensure GMP Laboratory Compliance
- Maintain testing proficiency for methods
- Ensure timeliness of lab results & investigations
- Perform analysis of samples
- Author deviations
- Coach other analysts
- Perform data trending & tracking
- Develop process competence across IFP/API
- Drive process improvement for Site QC
- Ensure all Analyst testing of samples is complete, as needed
- Ensure departmental documents are current & standardized
- Perform Laboratory Equipment Validation & System support
- Provide Laboratory IT System support
- Leverage solutions to other NNPILP sites
- Perform deviation & change control activities
- Support other NNPILP sites when relevant
- Support deviations
- Participate in Systematic Problem Solving
- Follow all safety & environmental requirements in the performance of duties
- Other accountabilities, as assigned
Physical RequirementsMoves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 20/25 based on role. May require colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.
Minimum Qualifications- Bachelor's Degree from an accredited university required
- May consider an Associate's Degree from an accredited university with seven (7) years of relevant experience in a clinical or industrial/pharmaceutical laboratory required
- Five (5) years of experience in a clinical or industrial/pharmaceutical laboratory required
- Ability to author scientific & technical reports required
- Able to perform routine testing per SOP & GMP standards required
- Advance level knowledge in GMP & laboratory techniques required
- Demonstrate attention to detail required
- Serve as a subject matter expert on QC processes required
- Strong communication skills (verbal & written) required
- Skills or knowledge in one of the following disciplines: Chemistry Analysis (HPLC, UPLC, GC, TOC, AA, UV, PH, KF), Microbiology Analysis (Isolator, Sterility, Bacterial Endotoxin testing, Growth Promotion and Microbial Identification, ELISA, BIOBURDEN) or Raw Materials Analysis (Compendial Testing, FTIR, NIR, Titration and UV-Vis) required
Preferred Qualifications- Advanced level of troubleshooting for laboratory equipment preferred
- Validation & technical transfer experience preferred
- Project Management experience is a plus
- Change control, deviation, trending preferred
